TRANSEAR BONE CONDUCTION HEARING AID
FDA 510(k) clearance K062404 · decided 2006-09-08
Clearance details
- K-number
- K062404
- Device name
- TRANSEAR BONE CONDUCTION HEARING AID
- Applicant
- Ear Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-17
- Decision date
- 2006-09-08
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Johnson City, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.